Associate Director, Risk based Quality Management (secondment & permanent)
ABOUT ASTRAZENECA
At AstraZeneca, we are united by a common purpose: to push the boundaries of science to deliver life-changing medicines. Every day, we make a difference by delivering potentially life-changing medicines to millions of people worldwide. Our purpose is results-oriented and so is our approach. Becoming a more agile and creative company means building a dynamic, inspiring culture where we celebrate diverse, bold thinking, are curious, creative, and open to new insights and ways of working.
JOB ROLE
Associate Director, Risk based Quality Management (AD, RBQM) drives RbQM process in assigned studies or projects to ensure compliance with ICH-GCP R2, AZ SOPs and to safeguard clinical trial integrity and patient’s safety.
AD RbQM works closely with Global Project and Study teams, Senior Specialist RbQM and Centralized Monitoring (CM) Clinical Data Scientists at the initial stages of the studies to define critical to quality factors, quality tolerance limits and risk management strategies as well as coordinates and oversees work of Senior Specialists RbQM and CM Data Scientists to define and execute Centralised monitoring support in eligible studies/projects.
AD RbQM contributes to RbQM process and CM strategy by driving standardization and defining best practices.
The role is available for both permanent and secondment (end date 31st of May 2025) position.
ACCOUNTABILITIES:
Leads RbQM process in eligible studies
Acts as subject matter expert (SME) in area of RbQM and risk management both internally and externally
Demonstrates good understanding of a broader CM strategy and contributes to it by driving cross functional innovation/optimization projects
Maintains a high level of understanding of regulatory agencies and other external and internal stakeholders’ requirements in terms of data quality
Engages project teams, global and local study steams during initial stages of studies in order to develop study specific critical to quality factors, acceptable defect rates, quality tolerance limits and risk management strategies
Develops, coaches, mentors, motivates and inspires individuals within the CM organization especially in the therapy area of interest
May oversee activities performed by Senior Specialist, RBQM
Contributes to the development of CM methodology and CM best practices
Expected to coach more junior staff and support functional development through e.g. recruitment, training and mentoring
Acts as SME on RbQM/CM in AZ optimization/best practices initiatives
ESSENTIAL EXPERIENCE/SKILLS:
Education: Minimum of a BSc degree in Life Science
Minimum of 4 years of experience in the Biotech/Pharma/CRO industry
Has a deep understanding of the clinical development and risk based monitoring and Centralised monitoring methodologies
Ability to define and lead improvement, innovation projects and interact with internal and external stakeholders at senior levels of management
Excellent communication skills in both written and spoken English
Strong Project Management and Risk Management skills
Ability to mentor, train and lead teams in projects
Agile responsiveness to industry and business needs and embracing peers’ review
Demonstrates strong cross-functional leadership skills
DESIRABLE:
Experience in Risk Based Monitoring/Centralised Monitoring is highly desired
Working in roles with global remit
Excellent understanding and demonstration of the AZ values and behaviours
Join AstraZeneca and help us deliver life-changing medicines. Be among our employees who continue to make us an innovation-driven company that stands firmly among the world’s leaders in biopharmaceuticals. APPLY!
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.
